In 2009, Ochsner Health Systems, in Louisiana decided to close its in vitro fertilization program because of multiple egregious mistakes in the embryology lab which resulted in making embryos from 15 women unusable. The errors were attributed solely to the embryologist who was not a hospital employee, but a contractor. The errors were two fold: labeling of embryos and FDA screening compliance errors. The embryologist and hospital system were both sued by patients who lost the use of their embryos because their embryos could not be identified or were not properly screened. The court case gave rise to the question as to whether an embryologist is a medical professional or something else.

Why would the professional status of embryologists matter? If embryologists are medical professionals, the state’s insurance fund would come into play and the damages claimed by the plaintiffs would be capped, limiting the financial exposure of the hospital. If embryologists were determined not to be medical professionals, then the case would be a case of simple negligence and no damage caps would apply. A report on the trial can be found in this New Orleans City Business article. Interestingly, the Louisiana Fifth Circuit Court of Appeal denied the hospital’s claim that it was a medical malpractice case and instead determined it was negligence, so damages were not capped. I don’t know if additional appeals are pending.

The issue of determining the type of error in the case revolved around determining whether embryologists are medical professionals or not. What was interesting to me was the testimony by John Richards, director of the IVF lab at the Center of Reproductive Medicine in Webster, Texas, who stated “that high school students could be trained to perform the tasks” that the embryologist was accused of screwing up. The argument being that anyone can label an embryo container properly and so embryologists are not medical professionals. I would argue that being a capable embryologist is more complicated than knowing simply how to label a container. A good embryologist usually knows more about embryology than your most accomplished high school student. They have the ability to stay highly focused on a task and are very detailed oriented- not traits attributable to most teenagers! They also have to have good technical (eye-hand coordination) skills and must feel a deep ethical obligation to their patients to do a near perfect job. The technical labeling is the least demanding piece but obviously, can never be taken for granted, done poorly or overlooked.

A group of high profile and accomplished embryologists and physicians serve on the advisory board for the American College of Embryology (ACE) whose purpose is “defining standards in clinical embryology”. ACE offers a program resulting in a certificate for embryologists at one of four levels, depending on meeting a combination of education and experience requirements and passing a certification exam. The certified embryologist must maintain certification by participating in on-going continuing education. You can read this open letter stating the rationale for the certification and the requirements and fees involved. It’s a good start but not enough.

Certification requirements for personnel working in clinical labs is not new. In 1988, the Clinical Laboratory Improvement Act set up legal requirements for performing laboratory testing which included personnel qualifications of laboratory technicians and laboratories. Lab directors were expected to become board certified as high complexity lab (HCLD) directors by passing several board exams. The American Board of Bioanalysts administered the board exams and was recognized by the federal government as a certifying agency . To sit for the exam, you needed to meet certain educational and on-the -job experience targets. Grandfathering was permitted so that individuals working in the field without the new education requirements would not find themselves unemployed.

The problem with CLIA ’88 was that the rules were enacted before embryologists and embryology practices were widespread so the regulations lacked specific professional requirements for personnel who were handling embryos, and only regulated personnel who were counting sperm. In 2002, ABB offered voluntary accreditation for technical non-PhD embryologists at several levels even though there was no federal requirement for embryology certification per se. The American College of Embryology (ACE) is second, newer certification agency that offers embryology specific courses, certification and examination. ACE also publishes Reproductive Biology Online, a reproductive journal.

Ironically, the state of California is considering legislation that would require specific regulation of IVF labs and embryologists, but the American College of Embryology has various issues and concerns with the proposed law. You can download the Press Release from their home page which outlines ACE’s reasons for why the proposed law (DH-08-001) should be rejected, primarily because the law proposes regulating human embryos as diagnostic specimens. This was pretty much the same problem that existed with the original CLIA ’88 regulations. Embryology did not fit well into the diagnostic clinical testing lab regulation model.

The ACE argument against the proposed California regulations is that unlike diagnostic specimens, embryos are not analyzed and discarded as medical waste. Tests performed on diagnostic specimens are evaluated as good tests based on accuracy, sensitivity and specificity of the test, standards that don’t come into play with embryos because there is no testing per se. In contrast, genetic testing labs that test parts of embryos (biopsied cells) are clinical testing labs and clearly fall under these regulations. Embryo labs create embryos for the express purpose of transfer to the uterus to produce a pregnancy, not to produce a lab result. The quality of performance in the embryology lab is measured by the clinics’ overall patient pregnancy rate, not accuracy, or timeliness of the test result. For these stated reasons, ACE believes standards developed for diagnostic specimens are not applicable to embryology. Furthermore, ACE argues that embryology should not be regulated “as either a diagnostic laboratory procedure or a medical practice”, but “a distinctive set of regulations must be developed specifically for this inimitable field.” Great, but who is going to do that?

Certification of embryologists is voluntary and so, by itself, is unlikely to result in widespread improvements in quality of services delivered by embryologists. There are no federal or state expectations (except in Florida) that embryologists be certified or have any minimal qualifications to be an embryologist. I think there should be more rigorous federal legal requirements for certification and perhaps even licensing of labs, as done in some countries. That’s an unpopular view within the US industry because no one likes to be regulated from outside but self-regulation of the fertility industry has been uniformly weak. We must do better.

In my opinion, certification alone will not necessarily improve an embryologist’s performance and pregnancy outcomes because certification does not guarantee that embryologists will follow the procedures that they have learned. When the Ochsner hospital system disaster was investigated, it came to light that the embryologist was not certified by the American Board of Bioanalysts (ABB) which offers board certification for embryologists. Based on his signature on some public chat boards, the embryologist may have had two other certifications common to embryologists, namely Medical Technician (MT) certification through the American Medical Technologists (AMT) and another certification through the American Association of Tissue Banks (AATB). If these certifications were valid, they obviously were not particularly effective in preventing poor practices. Certification is a necessary expectation for professionalism but is not enough to ensure safe effective practices. I think if you want to improve embryologists’ performance, the industry must establish best practices and have a mechanism to enforce compliance. Certification is meaningless if the certified individual then goes back into his lab and does his own thing which doesn’t work well.

But maybe I expect too much from voluntary certification programs when even the federal government lacks a means to enforce even the simplest protocols such as good labeling. For instance, Joint Commission inspectors who inspect labs for compliance with CLIA ’88 regulations can’t tell a lab how to properly label an embryo, just that a system must exist to identify embryos. When a standard is open to interpretation, you have people using non-permanent markers which dissolve, adhesive labels that fall off and labeling larger holding devices instead of the embryo straw or vial itself. All of these bonehead moves have lead to embryo loss and litigation. I think that the field has advanced to the point that the highest performing clinics can be identified and used as a template for best practices. Those best practices should then be enforced for a clinic to stay in business.

Off-site versus on-site lab direction. The other issue that arose from this case was the question of who had the responsibility to oversee the embryologist who made these errors? Well, there was a laboratory director in the Ochsner case but we never hear about him because he was an off-site director. Increasingly, lab directors exist as a signature scrawled on paperwork instead of a full time presence in the lab. Laboratory directors used to oversee a laboratory as full-time employees who were on-site and physically in the lab every day. But this traditional model is fading because it is expensive to hire a PhD employee to oversee the lab (salaries around $100,000 a year are fairly typical). It is much cheaper to hire a consultant lab director who oversees the paperwork from an off-site location (usually their main, often unaffiliated lab) to ensure compliance but only rarely steps into the lab. Consultants charge anywhere from $1000 to $5000 a month to oversee the lab. You do the math.

Legally, a high complexity lab director can oversee as many as five laboratories in a consultant capacity. There are few hard and fast rules for minimum engagement of the off-site lab director with the lab. Once a month visits are recommended by the professional societies. Once a quarter or far less are more typical, in my experience. So basically, the techs are usually on their own on a day to day basis. Yes, we have internet and telephone and faxes, but sometimes you just have to see the embryos and how procedures are being done. Over time, the way a protocol is actually done and how it is described in the protocol the lab director approves may drift apart. Depending on the quality and experience of the techs, being pretty much unsupervised can have varying results as you might imagine. As the economy declines, more and more lab owners are hiring off-site directors because it’s a cheap way to maintain compliance, at least on paper.

In the interests of full disclosure, I served as off-site lab director for a sister lab whose protocols and set-up were identical to the primary lab. Because of the mirrored protocols in both labs, I felt that I could effectively monitor the sister lab from afar because the rules, procedures and expectations were the same. Another factor that made the off-site direction an acceptable option for me was that I had a very senior and capable lab supervisor in place at the sister lab whom I trusted absolutely. Ironically, my own full time position was subsequently eliminated and I was replaced with an off-site director. My ambivalence regarding off-site direction was increased by my interview for an off-site position in which I effectively talked myself out of a job because I recommended to my prospective employer that in their particular situation with all kinds of protocol changes pending, they would be better served by having an on-site lab director. Probably not smart to argue against hiring yourself, but I just didn’t see a way to ethically deliver on expectations for a group that really needed daily intervention and hand-holding. So having been both kinds of lab director, I find it hard to argue that off-site oversight would be expected to improve the quality and safety of the lab. I would actually expect the opposite. Yet, off-site direction is becoming more and more common.

The bottom line is that IVF labs can deliver exceptional service to their patients but as the Ochsner case and too many others like it illustrate, sometimes the delivery of care can be very poor, even dangerous. The question for both IVF professionals and their patients is what can we do to raise the quality and safety standards of poorly performing labs to the level of the best labs and make the incidence of IVF disasters as close to zero as possible? Self-regulation is fine as long as it delivers high quality healthcare but in the current environment, full time lab oversight is dwindling and self-regulation through voluntary certification is looking increasingly inadequate.

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Fertility Lab Insider

Lessons learned from over fifteen years of working inside fertility labs.